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NCT04787328
A Single-arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC)
Phase 2 trial testing HA121-28 tablets in Medullary Thyroid Carcinoma in 30 participants. Status unknown.
1 March 2023
Quick facts
| Lead sponsor | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 13 July 2021 |
| Primary completion | 1 March 2023 |
| Estimated completion | 1 March 2025 |
| Sites | 13 locations across China |
Drugs / interventions tested
- HA121-28 tablets — full drug profile →
Conditions studied
- Medullary Thyroid Carcinoma — all drugs for Medullary Thyroid Carcinoma →
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Medullary Thyroid Carcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Objective remission rate (ORR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 60 months
assessed approximately every 8 weeks or 12 weeks based on the treatment cycle
Sponsor's own description
This is a single-arm, open-label, multicenter study designed to evaluate the preliminary antineoplastic activity, safety and tolerability of HA121-28 tablets administered orally in patients with medullary thyroid cancer (MTC).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Metastatic medullary thyroid carcinoma: a new way forward.
Angelousi A, Hayes AR, Chatzellis E, Kaltsas GA, et al · · 2022 · cited 30× · PMID 35521769 · DOI 10.1530/erc-21-0368 -
The Role of the Kinase Inhibitors in Thyroid Cancers.
Cuomo F, Giani C, Cobellis G. · · 2022 · cited 18× · PMID 35631627 · DOI 10.3390/pharmaceutics14051040 -
Selective RET Inhibitors (SRIs) in Cancer: A Journey from Multi-Kinase Inhibitors to the Next Generation of SRIs.
Clark L, Fisher G, Brook S, Patel S, et al · · 2023 · cited 6× · PMID 38201460 · DOI 10.3390/cancers16010031 -
The Evolving Treatment Landscape of Medullary Thyroid Cancer.
Laganà M, Cremaschi V, Alberti A, Vodopivec Kuri DM, et al · · 2023 · cited 6× · PMID 37979019 · DOI 10.1007/s11864-023-01145-5 -
Effects of Food on the Pharmacokinetics and Safety of HA121-28 Tablet, a Novel Multi-Targeting Tyrosine Kinase Inhibitor, in Healthy Chinese Subjects: A Phase I Clinical Trial.
Liu Y, Li X, Zhang M, Men Y, et al · · 2025 · PMID 39876990 · DOI 10.2147/dddt.s484310
Verify or expand the search:
- PubMed search for NCT04787328
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HA121-28 tablets
Trials testing the same drug.
- NCT04784520 — A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer · Phase 2 · terminated
- NCT03994484 — Study of Dosage Exploration and Pharmacokinetics for HA121-28 Tablets · Phase 1 · unknown
Other recruiting trials for Medullary Thyroid Carcinoma
Currently open trials in the same condition.
- NCT07383246 — CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC · Phase 3 · recruiting
- NCT07138716 — Research on the Application of 68Ga-DOTA-CCK-FS PET/CT in MTC · NA · recruiting
Other CSPC ZhongQi Pharmaceutical Technology Co., Ltd. trials
Trials by the same sponsor.
- NCT07532655 — A Single Ascending Dose Study of SYH2082 Injection in Healthy Participants · Phase 1 · not yet recruiting
- NCT07412353 — A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2085 · Phase 1 · recruiting
- NCT07282509 — Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of · Phase 1, PHASE2 · not yet recruiting
- NCT07418736 — A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease · Phase 2 · recruiting
- NCT07241936 — A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04787328 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Last refreshed: 7 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04787328.
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